Device recall
Z-1086-06: St. Jude AGILIS Steerable Introducer, Reorder number 408304 and 408308…
FDA device recall · Class II · St. Jude Medical / Daig Division
Key facts
| Recall number (Z-number) | Z-1086-06 |
|---|---|
| Recall event | 35300 |
| Product | St. Jude AGILIS Steerable Introducer, Reorder number 408304 and 408308 (Australia). Sterile EO. St. Jude Medical Daig Division, Inc., Minnetonka, MN 55345-2126 USA. This St. Jude Medical (SJM) Agilis Steerable Catheter Introducer Set consists of a dilator, guidewire, and steerable sheath, which is… |
| Product code | DYB |
| Recalling firm | St. Jude Medical / Daig Division |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 1, 2007 |
| 510(k) numbers | K042623 |
| FEI number | 2182269 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database